Our regulatory expert Ms Linda Mudyiwenyama who is supporting the Rwanda FDA has participated in the first face-to-face meeting of the WHO Advisory Group on Blood Regulation, Availability and Safety (AG-BRAS) held at WHO headquarters, Geneva, Switzerland on March 7-8, 2023. The Advisory Group functions to support programs and activities in blood regulation and transfusion ...
The World Health Organization (WHO) GSDP (Good Storage and Distribution Practices) standards (Annex 7 – TRS 1025 – Good storage and distribution practices for medical products ) published in 06/2020 is now available in French on the link Bonnes pratiques de stockage et de distribution des produits médicaux, as well as the “WHO Model guidance ...
Interview between the FDA’s Office of Global Policy and Strategy’s Communications Team and Dr. Paul Huleatt on the Member State Mechanism and his work as the Chair of the Mechanism’s Steering Committee. On top of being the Chair of the Mechanism’s Steering Committee, Dr. Huleatt represents Australia and the World Health Organization (WHO) Western Pacific ...
This WHO medical product alert refers to batches of TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1% manufactured by Galentic Pharma (India) Pvt. Ltd.This ointment is usually indicated for use in bacterial blepharitis, bacterial conjunctivitis, bacterial keratitis, and trachoma.However, five international procurers of the product independently conducted a visual examination of random samples of stock on hand ...
The World Health Organization is organizing a 5-day seminar in Geneva, aimed at professionals working in the pharmaceutical sector in low- and middle-income countries. The objective of this seminar is to allow participants to deepen their knowledge on critical issues such as the quality, supply, pricing issues, regulations, and falsified products, and understand how WHO ...
The following message is courtesy of Dr. Raffaella Ravinetto, Public Health Department, Institute of Tropical Medicine Antwerp, Belgium. Dear Friends, Sadly, I am sharing one more WHO Alert that concerns a poor-quality medicine that harmed children. As the Alert reads, “following adverse events in pediatric patients receiving METHOTREXTM 50mg, the health authorities in both Yemen ...
The QUAMED director Ed Vreeke participates in the Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers in Copenhagen ( 28 November-01 December 2022). The title of the meeting is Global Health Supplies: Paradigm Shifts in Market Authorization, Procurement and Supply Chains Approach. We are represented to learn more about the quality assurance systems of suppliers and the QA needs of procurers ...
The Utrecht WHO Collaborating Centre for Pharmaceutical Policy and Regulation is inviting researchers in the field of pharmaceutical policy analysis and regulatory science on 11-12 January 2023 for a Winter meeting, with keynote lectures to be delivered around the central theme of evidence generation along the drug life cycle and a thesis defence from Tina ...
QUAMED is part of the World Health Organization’s Coalition of Interested Parties As formulated by the WHO: “The purpose of CIP is to establish and promote a unified, strategic and coordinated approach to national and regional RSS, with a view to enhancing access to safe, effective and quality medical products”. This aligns perfectly with our vision and ...
The WHO Medical Product Alert refers to 8 sub-standard products, identified in South-East Asia. These products were identified in Indonesia and reported by the natural regulatory authority (Badan POM) on 20 and 30 Oct 2022. The 8 products were: Termorex syrup, Flurin DMP syrup, Unibebi Cough Syrup, Unibebi Demam Paracetamol Drops, Unibebi Demam Paracetamol Syrup, ...
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